Prilenia

Prilenia

Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU)

Boston, MA · Director · Full-time

Sponsorship not specifiedDetected 43 days ago
GCPClinical TrialsFDA RegulatoryPharmacovigilanceLeadershipCommunicationGxPBiostatisticsRegulatory Affairs

About the role

  • The role also provides proportionate QA oversight for pharmacovigilance (GVP) and pre - clinical (GLP) activities.
  • Ensure all Prilenia-sponsored trials are conducted, documented, and reported in compliance with applicable regulations, ICH guidelines, and Prilenia's SOPs.
  • Contribute to Prilenia's fit-for-purpose QMS, SOP lifecycle, quality event tracking, training, and regulatory intelligence.

Responsibilities

  • Serve as Prilenia's day-to-day QA lead for Phase 3 clinical operations, embedded in the program team from protocol review through clinical study report sign-off.
  • Act as sponsor QA counterpart to CRO QA teams and to Ferrer's QA function, maintain quality oversight of outsourced trial execution, align on standards, and manage issue escalation.
  • Oversee eTMF quality, manage protocol deviations and GxP non-conformances, drive CAPA resolution with CROs and sites, and maintain continuous inspection readiness.
  • Lead inspection readiness and management for regulatory authority inspections (FDA, EMA, MHRA, PMDA); serve as primary QA contact, coordinate responses to observations, and oversee regulatory commitment closure.
  • Author and maintain GCP and related SOPs; define and track quality metrics and KPIs for senior leadership.
  • Oversee clinical site, CRO, and vendor audits; review reports, manage CAPA resolution; review and approve Quality Agreements.
  • Serve as GVP QA partner and SME to Drug Safety: oversee PV systems, vendor quality performance, and vendor audits; support CAPA resolution for safety findings; ensure compliance with EU GvP modules, FDA 21 CFR Part 312, and ICH E2 series.
  • Serve as GLP QA partner and SME for externally conducted pre-clinical studies; ensure compliance with OECD Principles of GLP and applicable national regulations.

Requirements

  • Minimum 10 years of GCP QA experience within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership or director-level role at a biotech company.
  • Demonstrated expertise across GCP, GvP, and GLP quality frameworks
  • Deep knowledge of ICH E6(R2/R3), ICH E2 series, FDA 21 CFR Parts 11/50/54/56/312, EU Clinical Trials Regulation (No.
  • Proven experience leading or managing regulatory authority inspections (FDA, EMA, MHRA, or equivalent) to successful outcomes.
  • Proficiency with eTMF systems (e.g., Veeva Vault, Wingspan) and electronic QMS platforms.
  • Experience in neurology, neurodegenerative disease, or rare disease clinical programs.
  • Familiarity with risk-based monitoring (RBM), centralized monitoring, and ICH E6(R3) risk-proportionate approaches.
  • Experience supporting NDA/BLA/MAA submissions and post-approval quality oversight.
  • Knowledge of 21 CFR Part 11 / Annex 11 (computerized systems) and data integrity principles (ALCOA+).
  • Occasional travel including internationally within US and Europe required.
  • Required
  • hands-on experience conducting and managing audits in all three domains.
  • Deep knowledge of ICH E6(R2/R3), ICH E2 series, FDA 21 CFR Parts 11/50/54/56/312, EU Clinical Trials Regulation (No. 536/2014), EU GvP modules, and OECD Principles of GLP.
  • Experience building or significantly maturing a QMS in a small-to-mid-size pharmaceutical setting.
  • Exceptional communication skills
  • ab le to translate complex regulatory requirements into clear guidance for diverse audiences.
  • High ly autonomous, proactive, and resilient
  • comfortable in a fast-paced, resource-efficient environment.

Nice to have

  • Bachelor's degree or higher in life sciences, pharmacy, or a related discipline
  • advanced degree (MSc, PharmD) preferred.

Visa & Work Authorization

  • or clinical development, owning GCP quality end-to-end from study start-up through inspection readiness, and serving as sponsor QA counterpart to our CRO(s) and Ferrer's QA team
Apply directly at Prilenia →Create a free account for alerts like thisView Prilenia immigration profile

This listing is sourced directly from Prilenia's careers page and normalized into a canonical job model.